Details for New Drug Application (NDA): 212881
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The generic ingredient in CLOBETASOL PROPIONATE is clobetasol propionate. There are fourteen drug master file entries for this compound. Thirty-nine suppliers are listed for this compound. Additional details are available on the clobetasol propionate profile page.
Summary for 212881
Tradename: | CLOBETASOL PROPIONATE |
Applicant: | Alembic |
Ingredient: | clobetasol propionate |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 212881
Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Medical Subject Heading (MeSH) Categories for 212881
Suppliers and Packaging for NDA: 212881
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
CLOBETASOL PROPIONATE | clobetasol propionate | SOLUTION;TOPICAL | 212881 | ANDA | Alembic Pharmaceuticals Inc. | 62332-486 | 62332-486-25 | 1 BOTTLE in 1 CARTON (62332-486-25) / 25 mL in 1 BOTTLE |
CLOBETASOL PROPIONATE | clobetasol propionate | SOLUTION;TOPICAL | 212881 | ANDA | Alembic Pharmaceuticals Inc. | 62332-486 | 62332-486-50 | 1 BOTTLE in 1 CARTON (62332-486-50) / 50 mL in 1 BOTTLE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;TOPICAL | Strength | 0.05% | ||||
Approval Date: | Oct 21, 2019 | TE: | AT | RLD: | No |
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